Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weight-loss and Gut-brain Interactions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01740050
Recruitment Status : Unknown
Verified November 2012 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

While exposure to an obesogenic environment has increased for almost every individual in western society, not everyone is equally susceptible to overeating and not everyone becomes obese. Teasing apart the physiological underpinnings of those individual seemingly protective- differences may contribute to the development of successful preventive measures and treatment. Neuroimaging studies started to deliver important insights into the neuroanatomical determination of individual eating behavior. However, food intake is not only determined by the brain, but is orchestrated by an interaction of peripheral hormones with neural circuits and decision-making processes. This interactive axis is also referred to as the gut-brain axis. While individual aspects of the axis have been studied extensively, detailed insight in the interaction of gut and brain in the regulation of food intake is lacking.

Objective: The current study aims to investigate the effect of a) caloric restriction (very low calorie diet (VLCD)); b) caloric restriction with mechanical restriction (Laparoscopic adjustable gastric banding (LAGB)); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (Roux- en- Y bypass (RYGB) surgery) on gut-brain interactions to find an optimal balance for weight loss and long-term sustained weight maintenance.


Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Very Low Calorie Diet (VLCD) Procedure: RYGB Procedure: LAGB Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Different Weight-loss Methods on Gut-brain Interactions
Study Start Date : January 2013
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Roux- and Y bypas surgery (RYGB)
One subject group will lose 10% of initial body weight using RYGB. RYGB is an operation that first divides the stomach into a small upper pouch and a much larger lower "remnant" pouch and then re-arranges the small intestine to connect to both, in this way bypassing part of the small intestine.
Procedure: RYGB
Active Comparator: Laparoscopic adjustable gastric banding (LAGB)
One subject group will lose 10% of initial body weight using LAGB. With LAGB an inflatable band is placed around the upper part of the stomach to create a smaller stomach pouch. This slows and limits the amount of food that can be consumed at one time giving the opportunity for the sense of satiety to be met. It does not decrease gastric emptying time.
Procedure: LAGB
Active Comparator: Very Low Calorie Diet (VLCD)
One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.
Dietary Supplement: Very Low Calorie Diet (VLCD)
One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.




Primary Outcome Measures :
  1. the optimal interaction of gut hormones and brain activity [ Time Frame: 30 to 60 days: At baseline and after weight loss (10% of initial weight) ]

    To determine the optimal interaction of gut hormones and brain activity, resulting in successful weight loss and sustained weight maintenance. This objective will be investigated by examining the effect of a) caloric restriction (VLCD); b) caloric restriction with mechanical restriction (LAGB); and c) caloric restriction with mechanical restriction and physiological changes through malapsorption (RYGB) on food reward processing and decision-making in the brain and on gastrointestinal hormone release.

    The main parameters contributing to efficient, effective and satisfactorily weight maintenance at the same time is the change in satiety and in food reward upon an iso-energetic test-meal. This will be the main factor contributing to compliance and preventing reversal, (measured by visual analog scales (VAS), changes in ad libitum meal intake, representation in the brain of food reward processing and decision making, computer test, TFEQ for cognitive restraint, disinhibition and hunger).



Secondary Outcome Measures :
  1. gut-microbiota [ Time Frame: 30 to 60 days: At baseline and after weight loss (10% of initial weight) ]
    Possible changes in the gut-microbiota population, interacting with neuronal signaling for satiety and reward;

  2. body composition [ Time Frame: 30 to 60 days: At baseline and after weight loss (10% of initial weight) ]
    The weight loss itself and changes in body-composition; underscoring weight maintenance.

  3. endocannabinoid profile [ Time Frame: 30 to 60 days: At baseline and after weight loss (10% of initial weight) ]
    Possible changes in the endocannabinoid profile, interacting with neuronal signaling for satiety and reward

  4. Diet induced energy expenditure [ Time Frame: 30 to 60 days: At baseline and after weight loss (10% of initial weight) ]
    Changes in resting- and diet-induced energy expenditure; underscoring weight maintenance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: In order to be eligible to participate in this study, a subject must qualify for weight loss surgery with LAGB or RYGB, as evaluated by a physician at intake for surgery. Furthermore, subjects must meet all of the following criteria:

  • Subject, male or female, is age 18 to 60 years of age.
  • Subject must be able to understand and be willing to sign an informed consent document.
  • Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study.
  • Subject has a body mass index (BMI) of 40 - 45 or 35 to 39.9 plus one or more co-morbid diseases expected to improve with weight loss, including but not limited to hypertension, dyslipidemia, obstructive sleep apnea, or diabetes mellitus.
  • Subject must be of sufficient and stable medical health, as evaluated by physician at intake.
  • Subject must have failed standard obesity therapy of diet, exercise, behaviour modification, and pharmacologic agents either alone or in combination, as assessed at the intake for surgery by a physician.
  • For the fMRI measurements inclusion criteria are as follows: not having any metallic fragments in the body, being right-handed. Because of the different brain laterality in left- and right-handed subjects we chose to include only right-handed subjects. Hence the results can be compared between the subjects.

Exclusion Criteria:

  • - Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease, as evaluated by physician at intake for the surgery.
  • Subject has had significant weight loss in the last 3 months (>5kg).
  • Subject has a history or is diagnosed with eating disorders.
  • Subject has renal and/or hepatic insufficiency, as evaluated by physician at intake.
  • Subject has thyroid disease, which is not controlled with medication, as evaluated by physician at intake for the surgery.
  • Female subject who is pregnant (i.e., has a positive urine or blood pregnancy test prior to the procedure), is suspected to be pregnant, is lactating or is of childbearing potential but refuses to use adequate contraception during the study.
  • Female subject who started birth control pills less than 3 months before enrollment, or who plans to start taking birth control pills during the study.
  • Subjects who cannot discontinue either prescription or over the counter weight loss medications for at least 30 days prior to the start of the study as well as during the trial period.
  • Subjects who have started medications within the last 3 months that are known to cause weight gain.
  • Subjects who have cardiac pacemakers or other electronic implantable devices.
  • Subjects who have psychiatric disease including but not limited to manic-depressive disorder, schizophrenia, borderline personality disorder, depression or suicidal tendencies.
  • Subject currently uses or has a history of illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  • Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study.
  • Presence of contra-indications for f-MRI, as mentioned in the screening form and informed consent of the faculty of psychology (see section E2 and F1).
  • Claustrophobia
  • Being left-handed
  • Metallic fragments in the body

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740050


Contacts
Layout table for location contacts
Contact: Mieke JI Martens, Phd 0031433882124 ext 0031 mieke.martens@maastrichtuniversity.nl

Locations
Layout table for location information
Netherlands
Maastricht University (metabolic research unit Maastricht (MRUM))
Maastricht, Netherlands, 6229 ER
Contact: Mieke JI Martens, PhD    0031433882124 ext 0031    mieke.martens@maastrichtuniversity.nl   
Sub-Investigator: Mieke JI Martens, Phd         
Principal Investigator: Tanja C Adam, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Tanja C Adam, PhD Maastricht University
Layout table for additonal information
Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01740050    
Other Study ID Numbers: NL42676.068.12
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight